ENALAPRIL TEVA-RATIOPHARM 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Enalapril Teva-ratiopharm 5 mg Tablets EFG

enalapril maleate

Contents of the pack and other information

1. What is Enalapril Teva-ratiopharm and what is it used for
2. What you need to know before you take Enalapril Teva-ratiopharm
3. How to take Enalapril Teva-ratiopharm
4. Possible side effects
5. Storage of Enalapril Teva-ratiopharm

1. Contents of the pack and other information

1. What is Enalapril Teva-ratiopharm and what is it used for

Enalapril Teva-ratiopharm belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors)

Enalapril Teva-ratiopharm is indicated for:

• Treating high blood pressure (hypertension)
• Treating symptomatic heart failure
• Preventing symptomatic heart failure

This medicine works by widening your blood vessels, which makes it easier for your heart to pump blood around the body. It usually starts to work within an hour and its effect lasts for at least 24 hours. Some people may need several weeks of treatment before they get the full effect of this medicine on their blood pressure

2. What you need to know before you take Enalapril Teva-ratiopharm

Do not take Enalapril Teva-ratiopharm

• If you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6)
• If you have ever been treated for a condition called angioedema, which is characterized by swelling of the face, lips, tongue, or throat
• If you have ever had a serious reaction to a medicine similar to this one, known as an ACE inhibitor
• If you have diabetes or kidney problems and are taking a medicine called aliskiren
• If you are more than 3 months pregnant (also see the sections on “Pregnancy” and “Breast-feeding”)
• If you are taking a medicine called sacubitril/valsartan, used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine

Warnings and precautions

Consult your doctor or pharmacist before taking Enalapril Teva-ratiopharm

• If you have heart disease
• If you have a disease that affects the blood vessels in the brain
• If you have a blood disorder, such as a low or absent white blood cell count (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia)

If you have liver problems

• If you have kidney problems (including kidney transplant), follow a low-salt diet, take potassium supplements, or take medicines that can increase potassium levels in the blood, such as heparin (a medicine used to prevent blood clots), trimethoprim, or cotrimoxazole (medicines used to treat bacterial infections). This can lead to high levels of potassium in the blood, which can be serious. Your doctor may need to adjust your dose of enalapril or monitor your potassium levels in the blood. See also the information under the heading “Taking Enalapril Teva-ratiopharm with other medicines”
• If you are undergoing dialysis
• If you have recently had severe vomiting or diarrhea

• If you have diabetes, you should closely monitor your blood glucose levels, especially during the first month of treatment. Your potassium levels may also be higher

• If you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat, which made it difficult to swallow or breathe. You should be aware that patients of African descent are more sensitive to this type of reaction to ACE inhibitors
• If you have low blood pressure (you may feel dizzy or lightheaded, especially when standing up)
• If you have a disease of the connective tissue (such as lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, or are taking the medicines allopurinol or procainamide, or any combination of these

• If you are taking any of the following medicines, the risk of angioedema may be increased:
• racecadotril, a medicine used to treat diarrhea
• medicines used to prevent organ rejection and to treat cancer (e.g., sirolimus, everolimus, temsirolimus)
• vildagliptin, a medicine used to treat diabetes

• If you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARA) (also known as a “sartan”, e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes
• aliskiren

Your doctor may need to monitor your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals

See also the information under the heading “Do not take Enalapril Teva-ratiopharm”

You should inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking enalapril before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Enalapril Teva-ratiopharm. Enalapril Teva-ratiopharm is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy

You should be aware that this medicine is less effective at lowering blood pressure in black patients than in non-black patients

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine

If you are about to undergo a procedure

If you are about to undergo any of the following procedures, inform your doctor that you are taking enalapril:

• any surgery or if you are to receive anesthetics (even at the dentist)
• a treatment to remove cholesterol from your blood called “LDL apheresis”
• a desensitization treatment to reduce the effect of an allergy to bee or wasp stings

If any of the above applies to you, consult your doctor or dentist before undergoing the procedure

Taking Enalapril Teva-ratiopharm with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal remedies. This is because enalapril may affect the way other medicines work, and some medicines may affect the way enalapril works. Your doctor may need to adjust your dose and/or take other precautions

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Enalapril Teva-ratiopharm” and “Warnings and precautions”

• Other medicines to reduce blood pressure, such as beta blockers or diuretics
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant medicine used to prevent organ rejection; and heparin, a medicine used to thin the blood to prevent clots). See also the information in the section “Warnings and precautions”

• Medicines for diabetes (including oral antidiabetics and insulin)
• Lithium (a medicine used to treat certain types of depression)
• Medicines for depression called “tricyclic antidepressants”
• Medicines for mental problems called “antipsychotics”
• Certain medicines for cough and cold and weight loss medicines that contain a substance called a “sympathomimetic agent”
• Certain medicines for pain or arthritis, including gold treatment

• A medicine called an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or to prevent the immune system from rejecting a transplanted organ). See also the information in the section “Warnings and precautions”
• A medicine that contains sacubitril/valsartan, racecadotril, or vildagliptin. This may increase the risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). See also “Do not take Enalapril Teva-ratiopharm” and “Warnings and precautions”

• Non-steroidal anti-inflammatory medicines (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may be used to help relieve pain)
• Aspirin (acetylsalicylic acid)
• Medicines used to dissolve blood clots (thrombolytics)
• Alcohol

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking enalapril

Taking Enalapril Teva-ratiopharm with food, drinks, and alcohol

Enalapril can be taken with or without food. Most people take enalapril with a little water

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

Pregnancy

You should inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking enalapril before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Enalapril Teva-ratiopharm. Enalapril Teva-ratiopharm is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding is not recommended in newborns (first few weeks after birth), and especially in premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking enalapril, compared to other treatments, while breast-feeding

Driving and using machines

You may feel dizzy or drowsy while taking this medicine. If this happens, do not drive or use tools or machines

Enalapril Teva-ratiopharm contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine

This medicine contains less than 1 mmol sodium (23 mg) per tablet; this is essentially “sodium-free”

3. How to take Enalapril Teva-ratiopharm

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist

Remember to take your medicine

It is very important that you continue to take this medicine for as long as your doctor prescribes it

Do not take more tablets than your doctor has told you to

The recommended dose is:

Hypertension

The initial recommended dose is usually 5 to 20 mg once a day

Some patients may need a lower initial dose

The usual long-term dose is 20 mg once a day

The maximum long-term dose is 40 mg once a day

Heart Failure

The initial recommended dose is usually 2.5 mg once a day

Your doctor will gradually increase the dose until the appropriate dose for you is reached

The usual long-term dose is 20 mg per day in one or two divided doses

The maximum long-term dose is 40 mg once a day, divided into two doses

Patients with kidney problems

Your dose of medicine will depend on how well your kidneys are working:

• mild kidney problems - 5 mg to 10 mg per day
• moderate kidney problems - 2.5 mg to 5 mg per day
• severe kidney problems - 2.5 mg per day
• if you are undergoing dialysis - 2.5 mg per day. On days when you are not undergoing dialysis, your dose may need to be changed depending on how low your blood pressure is

Elderly patients

Your doctor will decide on the dose and will base it on how well your kidneys are working

Use in children

Experience with enalapril in children with high blood pressure is limited. If the child can swallow tablets, the dose will be calculated based on the child's weight and blood pressure. The usual initial doses are:

• between 20 kg and 50 kg - 2.5 mg per day
• over 50 kg - 5 mg per day

The dose may be adjusted according to the child's needs:

• up to a maximum of 20 mg per day in children who weigh between 20 kg and 50 kg
• up to a maximum of 40 mg per day in children who weigh over 50 kg

This medicine is not recommended in newborn babies (first few weeks after birth) or in pediatric patients with kidney problems

If you take more Enalapril Teva-ratiopharm than you should

If you take more enalapril than you should, contact your doctor or pharmacist immediately

Take the medicine pack with you

In case of an overdose, the most likely symptom is a feeling of dizziness or lightheadedness due to a sudden or excessive drop in blood pressure

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20, stating the medicine and the amount taken

If you forget to take Enalapril Teva-ratiopharm

You should continue to take this medicine as prescribed by your doctor. Do not take a double dose to make up for forgotten doses

If you stop taking Enalapril Teva-ratiopharm

Do not stop taking your medicine unless your doctor tells you to

If you have any further questions on the use of this medicine, ask your doctor or pharmacist

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following symptoms, stop taking this medicine and consult your doctor immediately:

• swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing,
• swelling of the hands, feet, or ankles,
• if you develop a red rash on the skin with swelling (hives).

You should be aware that black patients have a higher risk of suffering from this type of reaction. If you experience any of the above reactions, stop taking it and talk to your doctor immediately.

When you start taking this medicine, you may feel loss of consciousness or feel dizzy. If this happens, lying down can help. This is due to a decrease in your blood pressure. This will improve as you continue taking the medicine. If you are concerned, please talk to your doctor.

Other adverse effects include:

Very common(may affect more than 1 in 10 people):

• feeling of dizziness, weakness, or vomiting
• cough
• blurred vision

Common(may affect up to 1 in 10 people):

• dizziness due to low blood pressure, chest pain, changes in heart rhythm, angina pectoris, rapid heartbeats
• headache, depression
• difficulty breathing
• fatigue
• diarrhea, abdominal pain
• rash, allergic reactions with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing

• high levels of potassium in the blood, high levels of creatinine in the blood (both are usually detected in an analysis).

Uncommon(may affect up to 1 in 100 people):

• flushing
• sudden drop in blood pressure
• rapid and irregular heartbeats (palpitations)
• myocardial infarction or stroke possibly due to excessively low blood pressure in high-risk patients (patients with alterations in heart and/or brain blood flow)
• anemia (including aplastic and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, nervousness,
• feeling of itching or numbness in your skin
• vertigo (feeling of dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma-associated chest tightness
• slow movement of food through your intestine (ileus), pancreatitis, vomiting, indigestion, constipation, anorexia
• irritated stomach (gastric irritation), dry mouth, ulcer

• muscle cramps
• reduced kidney function or kidney failure
• increased sweating
• itching or hives
• hair loss
• malaise (general discomfort), elevated temperature (fever)
• impotence
• high levels of protein in your urine (determined in an analysis)
• low levels of sugar or sodium in the blood, high levels of urea in the blood (all determined in a blood analysis).

Rare(may affect up to 1 in 1,000 people)

• “Raynaud's phenomenon” in which your hands and feet can become very cold and white due to low blood flow
• changes in blood values, such as a lower number of white or red blood cells, lower hemoglobin, lower number of platelets in the blood
• bone marrow depression,
• inflamed glands in the neck, armpits, or groin.
• autoimmune diseases
• sleep disturbances or sleep problems
• fluid or other substance accumulation in the lungs (as seen on X-rays)
• inflammation of the nose
• inflammation of the lungs causing difficulty breathing (pneumonia)
• inflammation of the cheeks, gums, tongue, lips, throat
• reduction in the amount of urine produced
• target-shaped rash (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a severe skin disorder in which you have red and scaly skin, ulcers with blisters or open sores), exfoliative dermatitis/erythroderma (severe skin rash with scaling or peeling), pemphigus (small fluid-filled blisters on the skin)

• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzyme or bilirubin levels (determined in an analysis)
• breast enlargement in men (gynecomastia).

Very rare(may affect up to 1 in 10,000 people)

• Intestinal angioedema (swelling in the intestine)

Frequency not known(frequency cannot be estimated from available data)

• overproduction of antidiuretic hormone, leading to fluid retention, causing weakness, fatigue, or confusion
• a symptomatic complex has been reported that may include all or some of the following symptoms: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). Rash, photosensitivity, or other skin manifestations may occur.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Enalapril Teva-ratiopharm

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Store in the original package.

Do not use this medicine after the expiration date indicated on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Enalapril Teva-ratiopharm 5 mg tablets

The active ingredient of this medicine is enalapril maleate 5 mg. Each tablet contains 5 mg of enalapril maleate as the active ingredient.

The other ingredients are sodium croscarmellose, lactose monohydrate, magnesium stearate, pregelatinized starch (from corn), sodium bicarbonate, and cornstarch.

Appearance of the product and package contents

Enalapril Teva-ratiopharm 5 mg are circular, flat, scored, white tablets. They are available in packages of 10 or 60 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta

Alcobendas, 28108 Madrid (Spain).

Manufacturer:

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4.

50016 Zaragoza.

Date of the last revision of this prospectus:February 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66075/P_66075.html